A Bedtime Story for the Young Clinical Research Associate.

Second only to being a father to my son, the most important and fulfilling job I’ve ever had was being a Clinical Research Associate (CRA). Monitoring a study, like parenting a child, is a tremendous responsibility. When you are a Clinical Research Associate, millions of people — or perhaps that one innocent child — depend on you to ensuring the study integrity, so that only safe and effective products reach the marketplace.

Whenever someone gets rapid relief from a severe migraine, undergoes cardiac bypass surgery without needing a blood transfusion, or finds help for a number of other serious conditions, I get a warm feeling knowing I played an important role in the development of these medical products.

But the job can be frustrating at times. The travel can be brutal, and CRAs must constantly reconcile competing priorities. Investigators and Study Coordinators — your vitally important colleagues — have multiple responsibilities as well; they can’t drop everything just because you think a stubbed toe from twenty years ago should be recorded in the medical history. The Sponsor (read “your boss” even if your paycheck doesn’t say so!) is under crushing pressure to get safe and effective products to market faster, while under increasingly stringent regulatory scrutiny. Millions of potential users are counting on you to ensure that medical products doesn’t reach the market with unknown side effects, even if it is just an untoward effect on toes.

When my son, Zachary, asks me what I’ve done in my life, I will try to explain to him that my job as a CRA required a dual identity, what some might describe as “super powers.” I want my son to understand the critical importance of knowledge and skill in such a job. But more importantly, I want him to recognize that a positive attitude and sincere respect for your colleagues is the only way to achieve true success.

With the obvious embellishment that any good bedtime story deserves, I’ll tell my inquisitive offspring that I was once SuperMonitor, the mythical hero of coordinators and project managers alike. The story will go something like this.

A hero in the making

As our story unfolds, our hero is struggling to cram his regulation-size roll-aboard into a ridiculously small overhead bin. To protect his true identity, and for want of imagination, I’ll give our lead character a fictitious name, something so common that no one will suspect who he really is: Steve.{mosimage}

Steve smiles sheepishly at the long line of hurried travelers who impatiently wait for him to clear the aisle. As the flight attendant yells, “we need a seatbelt extender here!” A two-seat-wide young woman with a screaming baby on her hip pushes him angrily aside, squeezes into the aisle seat, flipping back the armrest: the last respite of privacy for a business traveler. A chatty old man who smells of a long day at the golf course has already claimed the window seat. Tripping over the woman and her boisterous offspring, Steve falls--or perhaps he is shoved--into 37-E, a center seat in the rear cabin. “Great! I’m in the choke & puke section,” he sarcastically grumbles.

He is hardly surprised when a sudden dampness reveals that the previous occupant soaked the seat cushion in coffee. “What else can go wrong?” he mutters under his breath, only to find that a passenger in row 36 has confiscated the storage space under the seat in front of him. The twenty pounds of case report forms (CRFs) in his scuffed briefcase--which Steve is now forced to hold for the duration of the flight--will make a nice level surface to balance his 15-pound “laptop” upon.

“Oh well, maybe I can finish that overdue monitoring report,” he thinks aloud, “assuming the blue screen of death doesn’t strike again!” His overpriced laptop is prone to such system crashes.

It’s the fourth cross-country trek this week for the battle-weary CRA, and with each skirmish, his attitude has descended further into the depths of despair. But his misery won’t end until he completes a routine monitoring visit to the office of his arch adversary, the notorious Dr. Freeze and his ever-elusive coordinator, Lexandra Luther. The fate of the free world--or at least the timely completion of the study--depends on his harvesting hundreds of CRFs for an unexpected data cutoff.

After the usual delay while the astronomically profitable airline tries to squeeze on a few more standbys, the plane pulls away from the gate. Only then does the pilot announce that the jet will park on the tarmac while mechanics do some routine scheduled maintenance. “Unfortunately, folks, this means we must shut down the engine and turn off the air conditioning,” the pilot says, “but bolting the wing back on--err, I mean completing the maintenance -- shouldn’t take more than a few hours.”

The copilot seizes the microphone and chimes in, “by the way, pay no attention to those men dressed in hazardous chemical disposal suits...they are simply here to clean up a spill in the rear of the aircraft...row 37, I think…there is absolutely no reason to worry that the brownish liquid might be toxic.”

At about the same time, several members of the Metropolis Junior High volleyball team, en route to regional finals, decide that this would be an excellent time to practice their spike. The short guy in row 37 (our hero) will make a good net.

In the many years since he left Smallville to work in the pharmaceutical industry, Steve has developed a vital survival skill for a road warrior: an uncanny ability to get lost in his thoughts. Despite the puddle of baby drool collecting on his shoes, the old man’s odoriferous requiem about the “back nine,” the stifling heat, and the deafening chants of the volleyball team, Steve sinks into a familiar voyage through the recesses of his mind. His high school girlfriend, the lovely blonde-haired Lois Lane, used to say in her best sing-song valley-girl voice, “It’s as if Steve were traveling through time and space in a cocoon-like vessel filled with the crystallized knowledge of a dying planet.” Lois was an aspiring poet.

This particular cerebral excursion is pitted against worries of Steve’s impending visit to Dr. Freeze and the crushing weight of the sponsor’s sudden data craving. Despite several reminder calls and a confirmation letter, it’s a safe bet, that the investigator and his coordinator will not be ready for Steve’s visit. About as reliable as the delivery boy for the Daily Planet, this less-than-dynamic duo can always find the time to put another subject into the trial, but never the time to first check the protocol’s inclusion/exclusion criteria.

Steve’s mental journey ends abruptly as the ancient aircraft--probably built by the Wright Brothers--violently pitches skyward. The turbulence is too much for the rusty overhead bin latch above row 37. Steve glances up just as his heavy suitcase from the Kryptonite luggage company hits him squarely on the forehead. Instantly, he is awash in a surrealistic world of primary colors straight out of the pages of a comic book. The dread he previously felt is suddenly replaced with a marvelous sense of free floating that only astronauts--or a superhero -- ever know.

He is no longer Steve the mild mannered CRA. He is SuperMonitor, the defender of truth, justice and the scientific method.{mosimage}

Milk, Cookies and a Change in Attitude

After a quick stop for milk and cookies, my son and I find that the pilot has miraculously landed the jet on time. SuperMonitor streaks off the plane faster than a speeding bullet, his sport coat flapping behind him like a cape in the wind. He easily negotiates rush hour traffic in a single bound and arrives at the investigator’s site to find that Lexandra Luther is extremely pleased to see him. SuperMonitor... defender of truth, justice and the scientific method.

“Please call me Lex,” she says cheerfully, “all of my friends do.” Lex leads him into a plush, quiet office, complete with a high-speed copier, fax machine, telephone, and a full complement of office supplies. She remarks how helpful SuperMonitor’s letter of confirmation had been and points to a stack of patient charts that she has already compiled for his review. With his keen, almost X-ray, vision, SuperMonitor spies a stack of resolved data queries, neatly arranged by subject number, ready for him to retrieve.

As he quickly works through his monitoring duties, he finds that Dr. Freeze has meticulously documented the study procedures and recorded the study results in the subject chart, and Lex has carefully transcribed the data to the CRFs. Before long, SuperMonitor completes his 100% verification of the CRF against the source documents, finding only a few minor queries. He examines the study files to ensure that all regulatory and documentation requirements have been met, and verifies that unused study medication has been counted and returned. Finally, he meets with Lex and Dr. Freeze to advise them of his findings and update them on the progress of the trial.

Using his nationwide cell phone, SuperMonitor makes a quick call to a local deli and orders lunch for the entire site staff, a small reward for their invaluable participation in the sponsor’s clinical development project. As he leaves the office, his supersonic hearing picks up Lex and Dr. Freeze calling the sponsor to let them know what a wonderful monitor he is. Chalk up another incredible feat for SuperMonitor!{quote_top}

Back on the streets of Metropolis cruising toward the airport, SuperMonitor suddenly spies in the heavens a spherical object rocketing toward town with a force more powerful than a steaming locomotive. Nearby, he hears a loud outcry from the well-dressed populace. A newspaper boy cries out “Look, up in the sky! It’s a bird.” A young woman with a baby boy on her hip shouts, “No, it’s a plane,” as she points at the white-hot projectile. With the self-sacrifice expected of a hero, SuperMonitor hurls his indestructible body in front of the woman and her little boy just as the deadly planetoid slams explosively into his chest. The woman and her child are saved. “Have no fear,” says SuperMonitor, “it’s only…a…a SPALDING!”

And the Moral of the Story

Knocked harshly back to reality by the whack of that all-too-real volleyball, Steve quickly recovers from the luggage lobotomy that launched him into his dream. After determining that the volleyball team’s spike into the human “net” did no harm to the woman and her small child, Steve hesitates, remembering the imminent monitoring visit.

Suddenly, he gleams with the discovery that he no longer fears his meeting with Lex Luther and Dr. Freeze. By some strange instantaneous transformation, he has developed an indestructible resolve and nerves of steel. Somehow, he now knows that he didn’t have to have been born on another planet to develop super powers. With the right attitude, anyone — even a monitor who sometimes gets grumpy when his job takes him away from his precious little boy — can be “super.”

…

And like this story, my son, with super powers comes a super responsibility. Steve knows his mission is to treat investigators, coordinators, his boss, the other travelers on his journey, and even airline companies, with respect and understanding. The world expects nothing less from a superhero.

This article was originally published in the July 1998 issue of Applied Clinical Trials magazine.